REDWOOD CITY, Calif., Nov. 4, 2010 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), today reported financial results for the third quarter ended September 30, 2010.
The net loss for the third quarter of 2010 was $5.9 million compared to $6.2 million for the third quarter of 2009. Research and development expenses were $4.8 million for the third quarter of 2010 compared to $4.0 million for the third quarter of 2009. The increase in research and development expenses primarily reflects an increase in clinical trial expenses related to TH-302. General and administrative expenses were $1.3 million for the third quarter of 2010 versus $1.2 million for the third quarter of 2009. This increase was primarily due to higher payroll and consulting expenses offset by lower employee stock-based compensation. Total non-cash stock compensation expense for the Company was $0.3 million for the third quarter of 2010 versus $0.5 million for the third quarter of 2009. The decrease in stock-based compensation expense is due to the amortization of options with lower valuations. Other income (expense) for the third quarter of 2010 was non-cash income of $0.1 million compared to non-cash expense of $1.0 million for the third quarter of 2009. This non-cash income was due to a decline in the fair value of the Company's outstanding warrants to purchase 10.9 million shares of common stock, which are classified as a liability.
For the nine months ended September 30, 2010, the net loss was $12.1 million, compared to $18.9 million for the nine months ended September 30, 2009. Research and development expenses were $14.2 million in the first nine months of 2010 compared to $11.7 million in the first nine months of 2009, and increased primarily due to clinical trial expenses related to TH-302. General and administrative expenses decreased to $3.6 million in the first nine months of 2010 from $4.1 million in the first nine months of 2009, primarily due to lower employee stock-based compensation. Total non-cash stock compensation expense for the Company was $0.5 million for the first nine months of 2010 versus $1.6 million for the first nine months of 2009. This decrease was primarily due to the amortization of options with lower valuations. Other income (expense) for the first nine months of 2010 was non-cash income of $5.6 million compared to non-cash expense of $3.0 million for the first nine months of 2009. This non-cash income was due to a decline in the fair value of the Company's outstanding warrants to purchase 10.9 million shares of common stock, which are classified as a liability.
As of September 30, 2010, Threshold had $20.1 million in cash, cash equivalents and marketable securities. For the nine months ended September 30, 2010, the Company's cash requirements were $17.2 million. Threshold currently expects that total operating expenses for 2010 will be between $23 and $25 million. Additionally, the Company continues to expect existing cash, cash equivalents and marketable securities to last through the second quarter of 2011.
Recent Highlights
- Completed patient accrual in the 402 trial (Phase 1/2 clinical trial of TH-302 in combination with chemotherapy in various solid tumors), with a total of 160 patients enrolled
- Presented top-line results from the 402 trial at the European Medical Oncology Society (ESMO) annual meeting
- Continued to enroll patients in the 403 trial (Phase 1/2 clinical trial of TH-302 in combination with doxorubicin in patients with soft tissue sarcoma)
- Continued to enroll patients in the 404 trial (Phase 2 controlled clinical trial of TH-302 in combination with gemcitabine in patients with advanced pancreatic cancer) and remain on track to complete patient accrual in 2011
Key Milestones
The Company currently anticipates the following clinical milestones related to TH-302:
- Report top line results from the 403 trial in the fourth quarter of 2010
- Report top line results from a Phase 1 open label clinical trial in advanced leukemias (the 407 trial) in the fourth quarter of 2010
- Report limited interim results from the 404 trial in the first half of 2011
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery and development of drugs targeting the tumor microenvironment. This approach offers broad potential to treat most solid tumors. By selectively targeting tumor cells, we are building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit our website (www.thresholdpharm.com).
Forward-Looking Statements
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates and approach to developing new product candidates, pre-clinical testing of TH-302, clinical trials and anticipated results and announcements, potential therapeutic uses and benefits of TH-302 and financial results, estimates, projections and requirements, including the need for additional cash. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to attract and retain employees, commence, enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which was filed with the Securities Exchange Commission on November 4, 2010 and is available from the SEC's website (www.sec.gov) and on our website under the heading "Investors". We undertake no duty to update any forward-looking statement made in this news release.
| THRESHOLD PHARMACEUTICALS, INC. | ||||
| (A Development Stage Enterprise) | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
| (in thousands, except per share amounts) | ||||
| (Unaudited) | ||||
| Three Months Ended | Nine Months Ended | |||
| September 30, | September 30, | |||
| 2010 | 2009 | 2010 | 2009 | |
| Revenue | $ -- | $ -- | $ -- | $ -- |
| Operating expenses | ||||
| Research and development | 4,773 | 3,973 | 14,194 | 11,719 |
| General and administrative | 1,297 | 1,235 | 3,591 | 4,115 |
| Total Operating Expenses | 6,070 | 5,208 | 17,785 | 15,834 |
| Loss from operations | (6,070) | (5,208) | (17,785) | (15,834) |
| Interest income (expense), net | 14 | 12 | 53 | (37) |
| Other income (expense) | 148 | (957) | 5,604 | (3,044) |
| Net Loss | $ (5,908) | $ (6,153) | $ (12,128) | $ (18,915) |
| Net loss per common share - basic and diluted | $ (0.18) | $ (0.40) | $ (0.36) | $ (1.24) |
| Weighted-average shares used in computing | ||||
| basic and diluted net loss per common share | 33,672 | 15,227 | 33,638 | 15,223 |
| THRESHOLD PHARMACEUTICALS, INC. | ||
| (A Development Stage Enterprise) | ||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||
| (in thousands) | ||
| September 30, | December 31, | |
| 2010 | 2009 | |
| (unaudited) | (1) | |
| Assets | ||
| Cash, cash equivalents and | ||
| marketable securities | $ 20,052 | $ 37,315 |
| Prepaid expenses and other current assets (2) | 765 | 10,342 |
| Property and equipment, net | 344 | 505 |
| Other assets | 761 | 523 |
| Total assets | $ 21,922 | $ 48,685 |
| Liabilities and stockholders' equity | ||
| Total current liabilities (2) | $ 3,336 | $ 12,874 |
| Long-term liabilities (3) | 7,379 | 13,154 |
| Stockholders' equity | 11,207 | 22,657 |
| Total liabilities and stockholders' equity | $ 21,922 | $ 48,685 |
| (1) Derived from audited financial statements. | ||
| (2) Includes as of December 31, 2009, $10 million of settlement costs to be paid to the plaintiffs of an outstanding class action lawsuit by the Company's insurers. During the second quarter of 2010 the settlement was approved by the Court and the $10.0 million was paid by the Company's insurers. | ||
| (3) Includes as of September 30, 2010 and December 31, 2009, $7.1 million and $12.7 million of warrant liability, respectively, as a result of the Company's adoption on January 1, 2009 of guidance now codified under ASC Topic 815, "Derivatives and Hedging." | ||